Recombinant Human Hyaluronidase Facilitated Subcutaneous Drug Delivery Using a 10mL High-Volume Auto-Injector

Partner Presentation Speaker(s)

• 

  David W. Kang

  Director, Drug Delivery
  Halozyme Therapeutics Inc
  San Diego, California

  Handouts
• 

  Michael Travanty

  Vice President - Product Development, Engineering
  Halozyme Therapeutics, Inc
  San Diego, California

Sponsored By:
Approvals of biologic therapeutics for subcutaneous (SC) administration continue to increase. Currently, more combination therapies are in development and being approved, and larger doses are often needed for optimal target product profiles; therefore, the need to deliver higher volumes continues to rise. In this presentation, we will discuss our high-volume auto-injector (HVAI) design process, and the use of recombinant human hyaluronidase (rHuPH20) to enable rapid large volume SC injections with a HVAI, including the clinical experience and tolerability of a 10 mL injection of a biologic in less than 30 seconds.

Learning Objectives:

• Describe how rHuPH20 depolymerizes hyaluronan in the SC tissue, significantly reducing tissue back-pressure typically associated with SC injections to expand the delivery rates and volume ranges that may delivered subcutaneously.
• Explain our approach for rapid development of an HVAI for human clinical studies.
• Demonstrate the feasibility of administering a SC injection of 10 mL of a biologic with rHuPH20, using an HVAI in healthy volunteers, who found the injections to be well-tolerated.